Global Implications of the EU’s Pharmacovigilance System Master File Requirements: Newly Developed Decision Trees to Distinguish Different Study Types

Abstract

In Europe, a new guideline on good pharmacovigilance practices–Module II: Pharmacovigilance system master file (PSMF)—was issued, and initially came into effect on 2 July 2012, with revision on 12 April 2013. The guideline describes the PSMF, which is a detailed description of the pharmacovigilance system and supports/documents its compliance with the requirements. Establishing and maintaining a PSMF is a global activity. However, because of differences or absence of regulations, legislation or guidance documents (soft laws) across the globe, definitions of studies may be different. However, as part of the PSMF, the marketing authorisation holder in Europe should be able to produce and make available a list including data arising from all study sources (the so-called ‘study list’) for inspection, audit and Qualified Person responsible for Pharmacovigilance oversight. For medicinal products authorised in Europe, this study list should describe, on a worldwide basis, the status of each study/programme, the applicable country(ies), the product(s) and the main objective. Most importantly, it should distinguish between non-interventional and interventional studies (clinical trials) and should be organised by active substance. The study list should include all ongoing studies/programmes as well as all studies/programmes completed in the last 2 years and may be provided as an annex to the PSMF or separately. This article analyses the global impact of the new European PSMF requirements, with special focus on the mandatory global study list. There are distinct differences between biomedical research, market research, patient support programmes and non-interventional and interventional studies, and a decision tree to support classification is proposed. This decision tree should improve harmonisation of study assessment and minimise inter-country variability in the presentation of studies/programmes for the PSMF.